Clinical trial · Interventional
Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35
Prospective Evaluation of PET-CT Scan in Patients With Non-operable or Non-resectable NSCLC Treated by Radical 3-Dimensional Conformal Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low levels of recruitment
Summary
Brief summary (as posted)
RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy. PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery. This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| computed tomography | Procedure | — | UNRESOLVED |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| radiation therapy treatment planning/simulation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3-DCRT
- description
- Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT
- interventionNames
- Procedure: computed tomography
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: fludeoxyglucose F 18
- Radiation: radiation therapy treatment planning/simulation
Primary outcomes (2)
- measure
- Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)
- timeFrame
- 2016
- measure
- Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II)
- timeFrame
- 2016
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell) * TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion * Measurable disease * No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous * Patient suitable for radical 3-DCRT * ECOG-Performance status ≤ 2 / KPS \> or equal to 60 * Weight loss \<10% within the 3 months prior to diagnosis * No prior radiotherapy to the thorax * Patient is suitable for lung-board immobilisation * No chemotherapy received prior to planning PET-CT scan * Age 18 and over * Provision of written informed consent Exclusion Criteria: * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol. * FEV1 \< 1
References
Publications (0)
Data not yet available